Orange Book product · Brand (NDA)
EVRYSDI
RISDIPLAM
At a glance
Feb 11, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 11, 2025
1 yr 4 mo ago
Today
Exclusivity ends · M-270
New use / labeling-change exclusivity (3 years)
Oct 03, 2026
in 4 mo
Patent 9586955 expires
Listed drug substance patent expiration.
Feb 08, 2033
in 6 yr 9 mo
Patent 9969754 expires
Listed drug substance patent expiration.
May 11, 2035
in 9 yr
Patent 11827646 expires
Listed method-of-use patent (U-1943) expiration.
Jan 25, 2036
in 9 yr 9 mo
Patent 12350273 expires
Listed method-of-use patent (U-1943) expiration.
Oct 01, 2038
in 12 yr 6 mo
Patent 11534444 expires
Listed method-of-use patent (U-1943) expiration.
Oct 04, 2038
in 12 yr 6 mo
Patent 12122789 expires
Listed drug substance patent expiration.
Apr 15, 2041
in 15 yr
Pharmaceutical detail
Active ingredient
RISDIPLAM
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219285
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- M-270New use / labeling-change exclusivity (3 years)
Oct 03, 2026
in 4 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9586955 | Feb 08, 2033 | in 6 yr 9 mo | SubstanceProduct |
| 9969754 | May 11, 2035 | in 9 yr | SubstanceProductU-1943 |
| 11827646 | Jan 25, 2036 | in 9 yr 9 mo | U-1943 |
| 12350273 | Oct 01, 2038 | in 12 yr 6 mo | U-1943 |
| 11534444 | Oct 04, 2038 | in 12 yr 6 mo | U-1943 |
| 12122789 | Apr 15, 2041 | in 15 yr | SubstanceProduct |
